Patients with non-healing wounds generally present a clinical condition with insufficient venous drainage in the patient's extremities such as in the legs. Cornerstone medical therapy for insufficient venous drainage is compression therapy, wherein a tight-fitting garment such as a stocking is worn over the extremity, or a wrapped bandage is applied to an affected area such as around the head. A conventional practice of compression therapy has been the use of compression stockings, which can be obtained in two pressure classes. One pressure class of compression garments, such as stockings, provides an external pressure to an extremity such as a leg with a pressure on an affected area up to 20 millimeters (“mm”) of mercury (“Hg”). The stockings can be obtained over-the-counter from a pharmacy without a physician's prescription. Another class of compression stockings provides an external pressure equal to or greater than 20 mm of Hg, and requires a physician's prescription. Prescribed compression stockings are obtainable in incremental pressure gradations of 10 mm of Hg.
A conventional compression stocking is generally designed with an elastic material that provides an initial pressure. The pressure produced and maintained by the stocking is not verifiable over time, however, particularly after periodic use and washing. A conventional compression garment frequently has a short useful life. Examples of conventional compression garments include Jobst™ stockings (compression garments), Unna™ paste boots, multi-layer wrapping systems, and various compression wraps.
A problem with conventional compression garments such as compression stockings is that patients under a physician's care are generally elderly, obese, arthritic, poorly conditioned, and may suffer from poor vision and/or a lack of coordination. The net result is the patient is frequently unable to put on a compression stocking without assistance, particularly when there are other comorbidities.
A compression garment improperly applied, such as with too much pressure or with unintended folds, can cause trauma to the patient's skin, particularly in an elderly or otherwise compromised patient. A compression garment with too tight of a fit can produce pressure ulcers comparable to bed sores. Conversely, a garment with reduced pressure is easier to put on, but does not provide a pressure necessary for a patient's treatment.
A problem with the current treatment of venous insufficiency includes patients not wearing compression garments due to inability to don and doff the garments easily. Another problem is the need to wear multi-layer and paste boots for a week at a time, which precludes many normal activities. Excessive heat generation, morbidity in obese and frail patients, atrophic members in patients, and patients with thin-skin and arthritis complicating the patient's ability to perform self-care are further concerns with the current treatment of venous insufficiency.
To illustrate the extent of venous disease in the United States, roughly 10 times more people suffer with venous disease than with arterial disease. At the present time, about 6,000,000 Americans have associated skin changes, and 500,000 Americans exhibit skin ulcers from underlying venous disease. In a typical year, about 600,000 Americans are hospitalized with venous disease issues. Chronic venous-lymphatic insufficiencies cause varicose veins, painful leg edema, chronic disfiguring skin changes, and difficult-to-heal ulcers. The compression garment industry to treat such patients is a multi-billion dollar industry worldwide.
Limitations of conventional processes to construct compression have now become substantial hindrances for reliable treatment of venous insufficiency. No satisfactory strategy has emerged to provide a reliable solution to provide a repeatable and controlled pressure in an extremity of a compromised patient. Thus, there is a need for a stocking or other compression garment that can be easily put on by a physically compromised patient without application of substantial force to an extremity such as a leg. After application, the garment should conform to the underlying shape of the affected area and apply a controlled and reliable level of pressure. The garment should provide practical long-term service after a reasonable number of applications and washings. Accordingly, what is needed in the art is a new approach that overcomes the deficiencies in the current solutions.